Cold chain distribution; route qualification approaches

Good Distribution Practices (GDPs) state that temperature-sensitive goods need to be distributed (stored, treated and transported) through the distribution network (manufacturers, service providers and customers) according to specified temperature conditions in order to preserve product quality , safety and efficacy during delivery. While GDPs are in place for some time, recent regulatory scrutiny reveals the importance of setting a company strategy for distributing sensitive products in compliance with product demands, industry regulations and industry standards, and industry initiatives and products that require special temperature conditions.

The goal of the cold chain management (quality system) processes is to establish processes to guarantee that products that are sensitive to temperature are preserved and complied with global regulations and industry standards. Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) are the starting point for the processes of cold chain management. GMPs aren't new, since they are commonly understood and have been in use for many years. GDPs have received increased focus for manufacturers recently, especially supply chain partners while expanding GMPs into the supply chain. The regulation of the distribution network by a supplier is far smaller than in manufacturing, but manufacturers should develop quality and operating systems / processes (internally and with supply chain partners), in order to maintain product quality, protection and effectiveness during delivery.

Good Distribution Procedures (GDPs) specify to distribute temperature-sensitive products (stored, handling and transportation) over the distribution network (hospitality supplier, service supplier and client) in accordance with certain conditions of temperature in order to maintain product quality , safety and effectiveness during distribution. As a result, cold chain management will concentrate on creating and enforcing the compliance mechanism for cold chain shipping and the cold chain management (quality system) mechanism. The continuous focus of Cold Chain management should be to support product stability for distribution and to strengthen cold chain management across the distribution network in partnership with service providers and clients.

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